Retrievable filter
A filter may have an apical hub and a plurality of divergent legs. A first attachment member may be separate from, but attached to the second end of at least one of the plurality of divergent legs. A second attachment member may be separate from, but attached to a stent. The first and second attachment members may be separate from, but attachable to one another to releasably attach the filter to the stent. One of the first attachment member and the second attachment member may include an attachment wire that is positioned in a lumen of a tubular member or one of the first attachment member and the second attachment member may comprise a cannula. In some implementations, an upward motion applied to the retrieval connection member may disengage at least one attachment wire of the first attachment member from the second attachment member.
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The present application claims the benefit of the filing date under 35 U.S.C. §119(e) of Provisional U.S. patent application Ser. No. 60/410,236, filed Sep. 12, 2002, which is hereby incorporated by reference.
BACKGROUND OF THE INVENTIONThe present invention relates to a blood filtration unit which is to be implanted inside a vessel of a patient's body.
Currently known filtration units are formed by at least one filter which is implanted intravenously, generally into the inferior vena cava, to capture blood clots which could migrate towards the heart, in order to avoid the risk of embolism.
Traditionally, blood filters have been classified in two categories: permanent filters and temporary, or retrievable, filters.
Permanent filters are designed to be implanted permanently in patients where the risk of embolism is chronic. Some conventional permanent filters have, for example, a frustoconical structure comprising a series of branches terminated by barbs, anchors or similar structures which enable the filter to be secured permanently to the vessel wall. Long-term risks associated with implantation of a permanent vena cava filter include venous stasis due to caval occlusion and its related complications. Although long term complication rates with permanent filters in patients are low, these can be avoided with the use of retrievable or temporary filters in patients with indications such as after severe trauma, and prior to extensive orthopedic or pelvic surgery.
Temporary filters are designed to be implanted temporarily in patients where the risk of blood clot migration lasts only for a brief period, usually a few weeks. Temporary filters differ from permanent filters basically in that they do not comprise hooks for securing to the vessel wall. The branches of the filter simply engage the vessel wall without hooking into it. Several temporary filtering devices have been developed for insertion into the inferior vena cava (IVC) by transcatheter technique.
Temporary filters are further classified as either tethered temporary or retrievable filters. Tethered temporary filters are modified catheters or intraluminal devices attached to a tethering catheter or a wire for retrieval one to six weeks after implantation. Tethered filters remain connected throughout the entire period of implantation to prevent the filter from migrating in the vessel. They are implanted in the infrarenal vena cava with the tethering catheter extending out of the puncture site in the neck or groin, or buried subcutaneously within the soft tissues in the patient's neck. The tether remains coupled to the filter after deployment and is later used to retrieve the filter. The potential for septic complications associated with the tethering catheter exiting the neck or groin require removal of such devices within fourteen days of placement. Risk periods for pulmonary embolism in such patients, however, can extend up to twenty-one weeks.
Retrievable filters are usually self-expanding and self-attaching devices which can be removed or, if desired, left in place permanently. Typically, these filters have a construction similar to some versions of permanent filters. A hook or similar grasping structure is provided to allow a snare to engage the filter during the retrieval procedure. The filter in its entirety is then retrieved using a snare by drawing it into a catheter. However, to ensure the filter does not migrate within the vessel, barbs, anchors or similar structures must be used to engage the filter with the interior wall of the vessel for retaining the filter in place. These anchors make removal without injuring the vessel difficult. Percutaneous retrieval of these devices requires a new jugular and/or femoral vein catheterization. There is approximately a two week period for removal or repositioning of the filter before it becomes fixed to the caval wall by endothelization. Most existing filters are not easily or safely removable after they have remained in place for more than two weeks, and consequently longer term temporary filters which do not result in the likelihood of injury to the vessel wall upon removal are not available.
In some patients, the risk of embolism remains great and continues over time contrary to what was expected. If a temporary filter has been implanted first, it is generally necessary to remove the filter in order to replace it by a permanent filter if the two week time period for removal or repositioning of the filter has been exceeded.
These problems are overcome through the use of a filter having a broad range of clinical utility with a long-term implantation period and at the same time a long-term retrievability option.
BRIEF SUMMARY OF THE INVENTIONIn a first aspect, the invention is a long-term retrievable, permanent filter for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel, said filter having two parts: a first part comprising a stent for positioning, engaging the vessel walls, and becoming incorporated by endothelial tissue; and a second part comprising a filter, said filter releasably coupled to said stent by a locking mechanism. After the risk of embolism has passed, the filter part may be retrieved using a catheter and snare. Alternatively, the filter may be left in place permanently if desired.
In another aspect, the invention is a long-term retrievable, permanent filter for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel comprising: (1) a stent for positioning, engaging the vessel walls, and becoming incorporated by endothelial tissue; (2) a filter; and (3) a locking mechanism for releasably coupling said stent to said filter; wherein said filter further comprises an apical hub, a plurality of divergent legs, at least one of said plurality of divergent legs secured at one end to said hub, at least one of said plurality of divergent legs releasably secured at another end, which is distally located with respect to said hub, to said stent by said locking mechanism. wherein said locking mechanism further comprises a stent attachment means and a filter attachment means.
In another aspect, the invention is a long-term retrievable, permanent filter for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel comprising: (1) a stent for positioning, engaging the vessel walls, and becoming incorporated by endothelial tissue; (2) a filter; and (3) a locking mechanism for releasably attaching said stent to said filter; wherein said filter further comprises an apical hub, a plurality of filter legs having an upstream end and a downstream end, at least one of said plurality of filter legs secured at the downstream end to said hub, at least one of said plurality of filter legs releasably secured at the upstream end to said stent by said locking mechanism.
In yet another aspect, the invention is a long-term retrievable, permanent filter for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel comprising: (1) a stent for positioning, engaging the vessel walls, and becoming incorporated by endothelial tissue; (2) a filter; and (3) a locking mechanism for releasably attaching said stent to said filter; wherein said filter further comprises an apical hub, a plurality of divergent legs having an upstream end and a downstream end, at least one of said plurality of divergent legs secured at the downstream end to said hub, at least one of said plurality of divergent legs releasably secured at the upstream end to said stent by said locking mechanism; wherein said locking mechanism further comprises stent attachment means attached to the downstream end of at least one of said plurality of divergent legs and at least one filter attachment means attached to said stent.
In yet another aspect, the invention is a long-term permanent retrievable filter for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel of a mammal comprising: (1) a filter comprising a plurality of divergent legs each having an upstream end and a downstream end, each of said plurality of divergent legs further comprising a cannula and a lumen; (2) an apical hub connecting each of said downstream ends of said plurality of divergent legs; (3) a stent configured to engage a wall of said generally tubular vessel and become incorporated by endothelial tissue; (4) a locking mechanism comprising a stent attachment means attached to said filter and a filter attachment means attached to said stent, said stent attachment means is releasably secured to said filter attachment means for releasably securing said filter to said stent, said stent attachment means further comprising at least one attachment wire, said at least one attachment wire extends through at least one lumen of said plurality of divergent legs and is attached at a retrieval connection point; wherein an upward motion applied to said retrieval connection point disengages said at least one attachment wire of said stent attachment means from said filter attachment means.
As noted above, the present invention relates to a number of different aspects of a long-term, retrievable, permanent filter. Schematic illustrations of the preferred embodiments are provided in
Referring to the drawings in detail, the invention as illustrated is embodied in a long-term retrievable, permanent filter 100 for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel 700 having two parts: a first part comprising a stent part 200 for positioning and engaging the vessel walls and becoming incorporated by endothelial tissue; and a second part comprising a filter part 300. A locking mechanism 500 releasably attaches the filter part 300 to the stent part 200. Preferably, locking mechanism 500 is a two part locking mechanism comprising a filter attachment means 510 and a stent attachment means 520, as described in further detail herein.
The stent part 200 of long-term retrievable, permanent filter 100 most preferably comprises a square stent as described herein. It is also anticipated that stents of the type described in U.S. Pat. No. 6,200,336, the disclosure of which is incorporated herein by reference, stents such as the Cook Z® Stent, stents of the type disclosed in U.S. Pat. Nos. 5,035,706 and 4,580,568, the disclosures of which are incorporated herein by reference, and other stents may be used in the alternative.
In the preferred embodiment shown in
Returning to
Preferably, stent part 200 further includes one or more barbs 16 to anchor stent part 200 following deployment as shown in
The stent part 200 further includes a filter attachment means 510 for attaching the filter part 300 to the stent part 200 to form the long-term retrievable, permanent filter 100. Preferably, the filter attachment means 510 comprises at least one cannulae 510 attached to the frame 11 as shown in
The filter part 300 of the long-term retrievable, permanent filter 100 may be a filter of the type described in U.S. Pat. Nos. 4,580,568, 5,035,706, 5,133,733, the disclosures of which are incorporated herein by reference, filters such as the Cook Günther-Tulip™ Vena Cava filter as well as other vena cava filters.
The filter legs 310-340 may be flexible wire and, in one preferred embodiment, the wires are metallic and round. In such an embodiment, the diameter of the wire may be between about 0.2 and about 0.4 millimeter, for example about 0.3 or about 0.35 millimeter.
Each leg comprises a central element 310a, 320a, 330a, 340a as well as two generally symmetrical curved side elements 310b, 320b, 330b and 340b and 310c, 320c, 330c and 340c extending on either side of each central element as best shown in
In the embodiment shown the two side elements of each leg 310-340 are formed from one piece of wire, the ends of which are held together in hub 350. At the middle of its length the wire piece may form an eyelet 310e, 320e, 330e, 340e surrounding the leg to be freely slidable along a part of the length thereof. Preferably, the side elements of each leg are formed from one piece of wire without the eyelet 310e-340e with the middle of the wire length attached to the leg as known in the art. By removing the eyelet 310e-340e, the potential that the wire crossing will be covered with neointima and potentially prevent retrieval is minimized. Preferably, the side elements of each leg have a length and a curvature such that, in the unfolded trumpet-like configuration of the filter part 300, the maximum distance between the side elements is of the same order as the distance between the neighboring side elements of two adjacent legs as shown in
As shown in
In alternate embodiments, the filter part 300 may be formed without curved side elements 310b-340b, 310c-340c and may comprise a plurality of elongated legs with different lengths, thicknesses and flexibilities.
Coatings, such as biocompatible polymeric coatings, and surface treatments, such as metallization with a noble metal can be applied to the legs 310-340. Also, each of the legs 310-340 may be coated with a polymeric, synthetic resin material having anti-thrombogenic properties.
The locking mechanism 500 comprises a filter attachment means 510 located on the stent part 200 and a stent attachment means 520 located on the filter part 300. The filter attachment means 510 releasably engages the stent attachment means 520, thereby releasably attaching the filter part 300 to the stent part 200. The locking mechanism 500 is sized to be large enough to remain locked during normal conditions, but small enough such that the force necessary to remove the filter part 300 does not damage the vessel during removal. It is believed that about 800 to about 1000 grams of force is the optimal force needed to remove the filter part 300 from the stent part 200. Preferably, locking mechanism directs the filter away from the wall of the lumen, as shown in
In the embodiments shown in
In the embodiment shown in
In the embodiment shown in
In an alternate embodiment shown in
In yet another alternate embodiment shown in
Still yet other embodiments of the locking mechanism 500 have been contemplated. In an alternate embodiment shown in
Other locking mechanisms may be used to fix the free ends of the filter part 300 to the stent part 200 to form the long-term retrievable, permanent filter 100 of the present invention without departing from the spirit or scope of the present invention. For example, brazing, welding, soldering, crimping, mechanical fasteners, twisting, gluing and the use of adhesives etc. may be suitable for some applications. Alternatively, at least one leg 310-340 of filter part 300 can be modified to releasably attach to stent part 200 directly. In yet alternative embodiments, filter attachment means 510 may comprise an attachment wire and stent attachment means 520 may comprise a cannula. Any structure capable of directing the filter part 300 away from the wall of the lumen is contemplated.
From the unfolded trumpet-like configuration illustrated in
In the alternate preferred embodiment shown in
In accordance with the invention, both the stent part 200 and the filter part 300 may be made of various materials, which can differ from each other, and can have different sizes and strengths. Preferably, the material is metal. Although the wire used in the preferred embodiments has a round cross-section, other shapes are also functional. In the preferred embodiment, the wire is preferably a radiopaque and non-ferromagnetic metal which has been certified for use in permanently implanted medical devices by the International Standards Organization (ISO). In particular, the wire may be made of a 316L stainless steel wire, or of a suitable grade of stainless steel such as that known as AFNOR K 13C20 N16 Fe15. Alternatively, the wire may be a high cobalt, low ferrous alloy, such as that known as and sold under the registered trademarks of “PHYNOX,” “ELGILOY” or “Conichrome” which may have the composition, by weight percent: cobalt 42%, chromium 21.5%, nickel 18%, iron 8.85%, molybdenum 7.6%, manganese 2% with the balance made up of carbon and beryllium having a maximum of 0.15% carbon and 0.001% beryllium. Also, the wire may be a nickel-chromium alloys, such as “MP35N” or that known as and sold under the registered trademark of “Inconel.” The wire may also be formed from titanium, titanium alloy, nickel titanium alloy known to be shape-memory metals which are sold and manufactured under the trademark “NITINOL”, an alloy of tantalum or any other biocompatible material with elasticity may in certain circumstances be employed to advantage. When a nickel titanium alloy is used, the wires are operating in the linear portion of the stress/strain curve of the alloy, though it is possible to employ wires operating in the super-elastic region while obtaining benefits of the invention. Likewise, thermally responsive shape-memory metal can be employed with the geometric and spatial constraints provided by the invention. Alternatively, the wire may be formed from various polymers. It is also anticipated that new materials, as they are developed, will be useful.
Preferably, the long-term retrievable, permanent filter 100 of the present invention is preferably constructed from materials that will preferably withstand twelve million respiratory cycles without mechanical failure and will be non-thrombogenic.
A long-term retrievable, permanent filter 100 according to the invention is positioned in a blood vessel according to the conventional process which is facilitated by the flexibility of the filter. For percutaneous insertion of long-term retrievable, permanent filter 100, a vein is punctured with a needle, and a guidewire is advanced into the blood vessel through the needle beyond the desired implantation site. A catheter consisting of an inner, dilating cannula within an outer sheath, up to 14 French in diameter, is then advanced into the vein, over the guidewire. When the desired implantation site is reached, the inner dilating cannula and guidewire are removed, leaving the sheath behind. The sheath acts as a conduit to permit the insertion of the filter. The long-term retrievable, permanent filter 100, in a collapsed configuration, is introduced into the sheath and advanced to the implantation site as shown in
A long-term retrievable, permanent filter 100 according to the invention is retrieved from a blood vessel by advancing a guidewire into the blood vessel to the implantation site. Then, advancing a catheter over the guidewire to the retrieval connection point 355 of the filter part 300. The guidewire is withdrawn and a retrievable loop is advanced through the collapsing catheter to the retrieval connection point 355 of filter part 300. The retrieval connection point 355 is grasped by the retrievable loop. As the retrievable loop is withdrawn, locking mechanism 500 releases filter part 300 from stent part 200 and filter part 300 is collapsed within the collapsing catheter.
Whereas the long-term retrievable, permanent filter 100 of the present invention has been described and illustrated with reference to a specific embodiment comprising four legs and a square stent it will be understood that various modification, e.g., with respect to the number of legs and/or the configuration of the stent can be made without departing from the scope of the following claims.
Claims
1. A retrievable filter for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel of a mammal comprising:
- a) a filter comprising an apical hub and a plurality of divergent legs including first and second ends, at least one of the plurality of divergent legs being secured at the first end to the apical hub;
- b) a first attachment member separate from, but attached to the second end of at least one of the plurality of divergent legs;
- c) a stent; and
- d) a second attachment member separate from, but attached to the stent, the first and second attachment members being separate from, but attachable to one another to releasably attach the filter to the stent, wherein one of the first attachment member and the second attachment member comprises an attachment wire and wherein the attachment wire is positioned in a lumen of a tubular member.
2. The retrievable filter of claim 1 wherein the stent is configured to engage a wall of the generally tubular vessel and become incorporated by endothelial tissue.
3. The retrievable filter of claim 1 further comprising a retention force capable of withstanding the liquid moving axially in the generally tubular vessel and a retrieval force to detach the filter from the stent, wherein the retention force is greater than the retrieval force.
4. The retrievable filter of claim 1 wherein the filter is configured to maintain its structure when the filter is detached from the stent.
5. The retrievable filter of claim 1 wherein the filter is configured to maintain its structure when the first attachment member is detached from the second attachment member.
6. The retrievable filter of claim 1 wherein the filter is configured to avoid contact with the generally tubular vessel.
7. The retrievable filter of claim 1 wherein at least one of the first attachment member and the second attachment member is configured to position the filter to avoid contact with the generally tubular vessel.
8. The retrievable filter of claim 1 wherein at least one of the first attachment member and the second attachment member is configured to position at least one of the plurality of divergent legs to avoid contact with the generally tubular vessel.
9. The retrievable filter of claim 1 wherein at least one of the first attachment member and the second attachment member is configured to avoid contact with the tubular vessel.
10. The retrievable filter of claim 1 wherein the stent is a square stent.
11. The retrievable filter of claim 1 wherein the stent is self-expanding.
12. The retrievable filter of claim 1 wherein the first attachment member and the second attachment member form an interference fit.
13. The retrievable filter of claim 1 wherein the attachment wire further comprises an extension of one of the filter and the stent.
14. The retrievable filter of claim 1 wherein the attachment wire further comprises a bend.
15. The retrievable filter of claim 1 wherein the attachment wire further comprises a ball and one of the first attachment member and the second attachment member further comprises a slot and a ball recess.
16. The retrievable filter of claim 1 wherein the attachment wire comprises a Y-shaped adapter.
17. The retrievable filter of claim 16 wherein the Y-shaped adapter further comprises a Y-shaped prong.
18. The retrievable filter of claim 1 wherein the attachment wire comprises a looped adapter.
19. The retrievable filter of claim 18 wherein the looped adapter further comprises a looped wire.
20. The retrievable filter of claim 1 wherein the attachment wire comprises a coiled adapter.
21. The retrievable filter of claim 20 wherein the coiled adapter further comprises a coil.
22. The retrievable filter of claim 1 wherein at least one of the first attachment member and the second attachment member further comprises a coiled attachment member, the coiled attachment member comprising at least one coil.
23. The retrievable filter of claim 22 wherein the at least one coil is formed from a shape memory alloy.
24. The retrievable filter of claim 1 wherein the retrievable filter is configured so that a user can decrease the force required to detach the filter from the stent to remove the filter.
25. The retrievable filter of claim 1 further comprising a retrieval connection member and at least one attachment wire attached thereto;
- wherein the at least one of the plurality of divergent legs further comprises at least one cannula and at least one lumen;
- wherein the at least one attachment wire extends from the retrieval connection member and through the at least one lumen;
- wherein the retrieval connection member further comprises a hook;
- wherein the hook is configured so that an upward motion applied to the hook disengages the at least one attachment wire of the first attachment member from the second attachment member.
26. The retrievable filter of claim 25 wherein the apical hub further comprises an apical hook.
27. The retrievable filter of claim 25 wherein the apical hub further comprises a locking ring.
28. A retrievable filter for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel of a mammal comprising:
- a) a filter comprising an apical hub and a plurality of divergent legs including first and second ends, at least one of the plurality of divergent legs being secured at the first end to the apical hub;
- b) a first attachment member separate from, but attached to the second end of at least one of the plurality of divergent legs;
- c) a stent; and
- d) a second attachment member separate from, but attached to the stent, the first and second attachment members being separate from, but attachable to one another to releasably attach the filter to the stent, wherein one of the first attachment member and the second attachment member comprises an attachment wire and wherein one of the first attachment member and the second attachment member comprises a cannula.
29. A retrievable filter for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel of a mammal comprising:
- a) a filter comprising a plurality of divergent legs each having an upstream end and a downstream end, each of the plurality of divergent legs further comprising a cannula and a lumen;
- b) an apical hub connecting each of the downstream ends of the plurality of divergent legs;
- c) a first attachment member separate from, but attached to at least one of the plurality of divergent legs, the first attachment member including at least one attachment wire, the at least one attachment wire extends through at least one lumen of the plurality of divergent legs and is attached to a retrieval connection member;
- d) a stent configured to engage a wall of the generally tubular vessel and become incorporated by endothelial tissue; and
- e) a second attachment member separate from, but attached to the stent, the first and second attachment members being separate from, but attachable to one another to releasably attach the filter to the stent,
- wherein an upward motion applied to the retrieval connection member disengages the at least one attachment wire of the first attachment member from the second attachment member.
30. A retrievable filter for filtering solid and semi-solid materials from a liquid moving axially in a generally tubular vessel of a mammal comprising:
- a filter comprising an apical hub and a plurality of divergent legs including first and second ends, at least one of the plurality of divergent legs being secured at the first end to the apical hub;
- a first attachment member separate from, but attached to the second end of at least one of the plurality of divergent legs;
- a stent comprising a frame including a closed circumference, the frame having a plurality of sides interconnected by a series of bends, each bend including a coil;
- a second attachment member separate from, but attached to the stent, the first and second attachment members being separate from, but attachable to one another to releasably attach the filter to the stent, at least one of the plurality of divergent legs of the filter being releasably secured at the second end to at least one of the plurality of sides of the stent by the first and second attachment members, wherein the filter and the stent are releasably secured to one another between an unattached position in which the first and second attachment members are not attached to one another and an attached position in which the first and second attachment members attach to one another; and
- wherein one of the first attachment member and the second attachment member comprises an attachment wire and wherein the attachment wire is positioned in a lumen of a tubular member.
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Type: Grant
Filed: Sep 12, 2003
Date of Patent: May 21, 2013
Patent Publication Number: 20040193209
Assignee: Cook Medical Technologies LLC (Bloomington, IN)
Inventors: Dusan Pavcnik (Portland, OR), Brian C. Case (Bloomington, IN), John A. Kaufman (Lake Oswego, OR), Michael L. Garrison (Bloomington, IN), Jacob A. Flagle (Bloomington, IN)
Primary Examiner: Tuan V Nguyen
Application Number: 10/662,216
International Classification: A61B 17/00 (20060101); A61F 2/06 (20060101); A61F 2/82 (20060101);